Successful Switch to Sanofi's Toujeo(R) Evaluated in a Real-World Setting

PR64759

PARIS, June 12 /PRNewswire=KYODO JBN/ --

     Sanofi announced today the release of the new real world data assessing

the use of Toujeo(R) (insulin glargine injection 300 Units/mL). The U.S.

Predictive Health Intelligence Environment (PHIE) database, containing a

substantial amount of patient level information, was analyzed to assess Toujeo

in this real life setting. The study examined electronic health records to

assess the change in HbA1c (average blood sugar levels) and occurrence of

hypoglycemia in patients up to 6 months after switching to Toujeo from another

basal insulin. The results of the study were presented on June 11 at the

American Diabetes Association 76th Scientific Sessions in New Orleans, LA,

U.S.A.

    "In the first evaluation of Toujeo in the real-world care setting, it is

encouraging for the treatment of adults with type 2 diabetes to see the

successful switching to Toujeo from another basal insulin," said Riccardo

Perfetti, Head of Global Diabetes Medical Team, Sanofi.

    "This study adds to the growing evidence in the knowledge of the use of

Toujeo, in patients with Type 2 diabetes," said Professor Robert Ritzel, a

Toujeo clinical trials program investigator and Head Physician of the Clinic

for Endocrinology, Diabetes and Addiction Medicine, Schwabing Hospital, Munich,

Germany. "While adequate and well-controlled clinical trials are vital for

regulatory requirements and guidance of clinical decision making, further

evidence in a real-world care setting is particularly relevant for health-care

professionals, payers and other organizations when assessing safety and

efficacy in larger patient populations and cost-effectiveness."

    Sanofi is committed to evaluate Toujeo in the real life settings and is

conducting three large studies called ACHIEVE, REACH and REGAIN CONTROL in type

2 diabetes patients starting basal insulin treatment or switching from another

basal insulin  These studies involve more than 4,500 patients across the U.S.

and Europe. Initial results of the Real-Life Study Program are anticipated in

2017.

    Results of Analysis

    Adults with type 2 diabetes who had used other basal insulins within the 6

months prior to Toujeo initiation (one or more prescription order of Toujeo

between March 2015 and December 2015) were identified. The PHIE records of

those identified (N=881) were assessed for HbA1c and incidence of confirmed

(less than or equal to70 mg/dL) or severe hypoglycemia up to 6 months prior to

and up to 6 months after initiation.

    Among the subpopulation of patients (n=267) with HbA1c measured at baseline

and during follow-up (0-6 months), mean HbA1c was 8.97% at baseline and 8.33%

at follow-up. For the subpopulation of patients (n=449) with occurrence of

hypoglycemia measured at baseline and during follow-up (0-3 months), this was

6.0% at baseline and 5.1% at follow-up.

    The study abstract is titled: Real-World Assessment of Patient

Characteristics and Clinical Outcomes of Early Users of the New Insulin

Glargine 300U/mL (Ye, F et al. Poster presentation 943-P, American Diabetes

Association 76th Scientific Sessions, New Orleans, LA, U.S. Saturday, June 11,

2016).

    About ACHIEVE, REACH and REGAIN CONTROL

    The ACHIEVE CONTROL study will evaluate the effect of Toujeo(R) on

achieving individualized glycemic targets without hypoglycemia at any time of

day in 3,270 uncontrolled insulin-naive people in the U.S. with type 2 diabetes.

    The REACH CONTROL will follow 800 insulin-naive people with type 2 diabetes

in Europe, comparing HbA1c change with Toujeo(R) vs. other basal insulins,

alongside incidence of hypoglycemia, change in body weight, and measures of

persistence with treatment and need for treatment intensification.

    The REGAIN CONTROL study will compare HbA1c reduction, incidence of

hypoglycemia, change in body weight and persistence with treatment on Toujeo(R)

vs. other basal insulins in 600 people with type 2 diabetes in Europe, who are

currently uncontrolled on basal insulin. In addition to clinical measures, the

studies will also collect patient feedback on treatment satisfaction and their

experience of hypoglycemia, along with healthcare resource utilization.

    About Toujeo(R)

    Toujeo is a once-daily basal insulin based on a broadly-used molecule

(insulin glargine). Toujeo has been approved by the U.S. Food and Drug

Administration (FDA), the European Commission, Health Canada, the Therapeutic

Goods Administration in Australia, and the MHLW in Japan (where its approved

brand name is Lantus(R) XR), and is under review by other regulatory

authorities around the world.

    What is Toujeo(R) (insulin glargine injection) 300 Units/mL?

    Prescription Toujeo(R) is a long-acting insulin used to control blood sugar

in adults with diabetes mellitus.

    - Toujeo(R) contains 3 times as much insulin in 1 mL as standard insulin

      (100 Units/mL)

    - Toujeo(R) is not for use to treat diabetic ketoacidosis

    - Toujeo(R) should not be used in children

    Important Safety Information for Toujeo(R) (insulin glargine injection) 300

Units/mL

    Do not take Toujeo(R) during episodes of low blood sugar or if you are

allergic to insulin or any of the ingredients in Toujeo(R).

    Do NOT reuse needles or share insulin pens even if the needle has been

changed.

    Before starting Toujeo(R), tell your doctor about all your medical

conditions, including if you have liver or kidney problems, if you are pregnant

or planning to become pregnant or if you are breast-feeding or planning to

breast-feed

    Heart failure can occur if you are taking insulin together with certain

medicines called TZDs (thiazolidinediones), even if you have never had heart

failure or other heart problems. If you have heart failure, it may get worse

while you take TZDs with Toujeo(R). Your treatment with TZDs and Toujeo(R) may

need to be changed or stopped by your doctor if you have new or worsening heart

failure. Tell your doctor if you have any new or worsening symptoms of heart

failure, including:

    - Shortness of breath

    - Swelling of your ankles or feet

    - Sudden weight gain

    Tell your doctor about all the medications you take, including OTC

medicines, vitamins, and supplements, including herbal supplements.

    Toujeo should be taken at the same time once a day. Test your blood sugar

levels daily while using any insulin, including Toujeo(R). Do not make changes

to your dose or type of insulin without talking to your doctor. Verify you have

the correct insulin before each injection. Your dose for Toujeo(R) may be

different from other insulins you have taken. Any change of insulin should be

made cautiously and only under medical supervision.

    Do NOT dilute or mix Toujeo(R) with any other insulin or solution. It will

not work as intended and you may lose blood sugar control, which could be

serious. Use Toujeo(R) only if the solution is clear and colorless with no

particles visible.

    While using Toujeo(R), do not drive or operate heavy machinery until you

know how Toujeo(R) affects you. You should not drink alcohol or use other

medicines that contain alcohol.

    The most common side effects of any insulin, including Toujeo(R), is low

blood sugar (hypoglycemia), which may be serious and can be life-threatening.

Severe hypoglycemia may cause harm to your heart or brain. Symptoms of serious

low blood sugar may include shaking,  sweating, fast heartbeat, and blurred

vision.

    Toujeo(R) may cause serious side effects that can lead to death, such as

severe allergic reactions that affect the whole body. Get medical help right

away if you have:

    - A rash over your whole body

    - Trouble breathing

    - Shortness of breath

    - Fast heartbeat

    - Swelling of your face, tongue, or throat

    - Sweating

    - Extreme drowsiness, dizziness, or confusion

    Toujeo(R) may have additional side effects including swelling, weight gain,

low potassium, and injection site reactions which may include change in fat

tissue, skin thickening, redness, swelling, and itching.

    Please see full Prescribing Information for Toujeo(R) on Toujeo.com or

click here: http://products.sanofi.us/Toujeo/Toujeo.pdf

    About Sanofi

    Sanofi, a global healthcare leader, discovers, develops and distributes

therapeutic solutions focused on patients' needs. Sanofi is organized into five

global business units: Diabetes and Cardiovascular, General Medicines and

Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed

in Paris (EURONEXT: SAN

[http://en.sanofi.com/investors/share/stock_chart/stock_chart.aspx ]) and in

New York (NYSE: SNY

[http://en.sanofi.com/investors/share/stock_chart/stock_chart.aspx ]).

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    SOURCE: Sanofi